Chen Xiu-Min, Wu Jia-Qi, Huang Qing-Chun, Zhang Jian-Yong, Pen Jian-Hong, Huang Zhi-Sheng, Chu Yong-Liang, He Xiao-Hong, Wang Mao-Jie, Huang Run-Yue
Department of Rheumatology, The Second Affiliated Hospital, (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510006, P.R. China.
Postdoctoral Mobile Research Station, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510006, P.R. China.
Exp Ther Med. 2018 Jun;15(6):5221-5230. doi: 10.3892/etm.2018.6121. Epub 2018 May 2.
Biqi capsule is a Traditional Chinese Medicine preparation for treating rheumatoid arthritis (RA), and clinical studies have indicatedthat its effect may be more beneficial than that of Western medicine. The present study aimed to estimate the efficacy and safety of Biqi capsule alone or combined with methotrexate (MTX) compared with MTX alone for treating RA by performing a meta-analysis of randomized controlled trials and controlled clinical trials. A systematic literature search of studies published until March 2017 was performed. References from relevant studies were screened to obtain additional articles. The results were independently evaluated for relevance, and full-text studies were assessed for eligibility. The risk of bias was assessed using the Cochrane collaboration tool for assessing risk of bias. Out of 558 citations that were initially retrieved, a total of 5 studies comprising 522 patients met the inclusion criteria. The risk of bias of these trials was generally unclear or high. Meta-analysis indicated that Biqi capsule had better effects on C-reactive protein [standardized mean difference (SMD), -7.05; 95% CI -(10.77-3.33)] and tender joint count [SMD, -3.02; 95% CI, -(3.81-2.22)] and fewer adverse effects (AEs) than MTX [relative risk (RR), 0.19; 95% CI, 0.08-0.43]. Biqi capsule plus MTX was superior to MTX in terms of the total effect (RR, 1.17; 95% CI, 1.06-1.28), rheumatoid factor [SMD, -12.54; 95% CI, -(16.87-8.20)], swollen joint count [SMD, -1.50; 95% CI, -(1.99-1.01)], score of joint swelling [SMD -2.07; 95% CI, -(2.76-1.38)], tender joint count [SMD, -2.16; 95% CI, -(2.86-1.47)] and score of joint tenderness [SMD, -4.69; 95% CI, -(5.92-3.47)]. There was no difference in AEs between Biqi capsule plus MTX and MTX (RR, 0.71; 95% CI, 0.34-1.50). In conclusion, the present study indicated that compared with MTX, Biqi capsule plus MTX appeared to have more benefits but that Biqi capsule alone was not better for RA patients than MTX. In the other words, Biqi capsule plus MTX is more effective and has fewer AEs compared to MTX. However, the trials selected in the present meta-analysis have various limitations, including the lack of blinding and the short duration of the treatment; therefore, the conclusions are not sufficiently definitive. More randomized controlled trials are necessary to evaluate the use of Biqi capsule for managing RA.
痹祺胶囊是一种用于治疗类风湿关节炎（RA）的中药制剂，临床研究表明其疗效可能比西药更具优势。本研究旨在通过对随机对照试验和对照临床试验进行荟萃分析，评估单独使用痹祺胶囊或与甲氨蝶呤（MTX）联合使用相较于单独使用MTX治疗RA的疗效和安全性。我们对截至2017年3月发表的研究进行了系统的文献检索。筛选相关研究的参考文献以获取更多文章。对结果进行独立的相关性评估，并对全文研究进行资格评估。使用Cochrane协作工具评估偏倚风险。在最初检索到的558篇文献中，共有5项研究（包含522例患者）符合纳入标准。这些试验的偏倚风险普遍不明确或较高。荟萃分析表明，与MTX相比，痹祺胶囊在降低C反应蛋白方面效果更好[标准化均数差（SMD），-7.05；95%置信区间，-(10.77 - 3.33)]，压痛关节数减少[SMD，-3.02；95%置信区间，-(3.81 - 2.22)]，且不良反应（AE）更少[相对危险度（RR），0.19；95%置信区间，0.08 - 0.43]。痹祺胶囊联合MTX在总疗效（RR，1.17；95%置信区间，1.06 - 1.28）、类风湿因子[SMD，-12.54；95%置信区间，-(16.87 - 8.20)]、肿胀关节数[SMD，-1.50；95%置信区间，-(1.99 - 1.01)]、关节肿胀评分[SMD，-2.07；95%置信区间，-(2.76 - 1.38)]、压痛关节数[SMD，-2.16；95%置信区间，-(2.86 - 1.47)]和关节压痛评分[SMD，-4.69；95%置信区间，-(5.92 - 3.47)]方面均优于MTX。痹祺胶囊联合MTX与MTX在AE方面无差异（RR，0.71；95%置信区间，0.34 - 1.50）。总之，本研究表明，与MTX相比，痹祺胶囊联合MTX似乎更具优势，但单独使用痹祺胶囊对RA患者并不比MTX更好。换句话说，与MTX相比，痹祺胶囊联合MTX更有效且AE更少。然而，本荟萃分析中所选试验存在各种局限性,包括缺乏盲法和治疗持续时间短；因此，结论不够明确。需要更多的随机对照试验来评估痹祺胶囊在治疗RA中的应用。
